Spots Global Cancer Trial Database for MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01)
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Trial Identification
Brief Title: MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01)
Official Title: Open-label, Multicentre, Phase Ib/II Study of MEN1611, a PI3K Inhibitor, and Cetuximab in Patients With PIK3CA Mutated Metastatic Colorectal Cancer Failing Irinotecan, Oxaliplatin, 5-FU and Anti-EGFR Containing Regimens
Study ID: NCT04495621
Conditions
Study Description
Brief Summary: Open-label, dose-confirmation and cohort expansion, multicentre, Phase Ib/II study to assess the anti-tumour activity and safety of MEN1611 in combination with cetuximab for the treatment of patients with PIK3CA mutated metastatic colorectal cancer.
Detailed Description: This Phase Ib/II study will investigate the anti-tumour activity and safety of daily oral doses MEN1611 in combination with cetuximab in female and male patients affected by PIK3CA mutated, N-K-RAS wild-type and BRAF wild-type metastatic colorectal cancer. MEN1611 is a potent, selective Class I phosphoinositide 3-kinase (PI3K) inhibitor. The Maximum Tolerated Dose (MTD) of MEN1611 given as single agent was assessed in a phase I trial in patients with advanced solid tumors. This Phase Ib/II will start with a dose confirmation part (Step 1) to identify the RP2D of MEN1611 given in combination with cetuximab. The study will continue with a cohort expansion (Step 2) to explore the anti-tumour activity of the selected MEN1611 dose level combined with cetuximab with further assessment of their safety and tolerability.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Arizona, Phoenix, Arizona, United States
The Oncology Institute of Hope and Innovation, Anaheim, California, United States
MultiCare Health System Institute for Research and Innovation, Tacoma, Washington, United States
ICO - Site Paul Papin, Angers, , France
Centre Georges François Leclerc, Dijon, , France
ICO - Site René Gauducheau, Saint-Herblain, , France
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin, , Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden, Dresden, , Germany
Klinikum der Universitaet Muenchen Campus Grosshadern, Munich, , Germany
Munich, Munich, , Germany
Universitaetsklinikum Tuebingen, Tuebingen, , Germany
Azienda Ospedaliero Universitaria San Martino, Genoa, , Italy
Istituto Europeo di Oncologia (IEO), Milan, , Italy
Azienda Socio Sanitaria Territoriale Niguarda, Milan, , Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, , Italy
Istituto Clinico Humanitas, Rozzano, , Italy
Amsterdam University Medical Center, Amsterdam, , Netherlands
Maastricht University Medical Center, Maastricht, , Netherlands
Radboud Nijmegen, Nijmegen, , Netherlands
Erasmus Medisch Centrum, Rotterdam, , Netherlands
Examen sp. z o.o., Skórzewo, , Poland
Centrum Onkologii-Instytut im.M.Sklodowskiej Curie, Warsaw, , Poland
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Fundacion Jimenez Diaz, Madrid, , Spain
Centro Integral Oncologico Clara Campal, Madrid, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Contact Details
Name: Josep Tabernero, MD PhD
Affiliation: Vall d' Hebron Institute of Oncology (VHIO), Barcelona, Spain
Role: STUDY_CHAIR
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